Hypodermic Needle-Pro EDGE Safety Device
FDA 510(k) K211634 · Smiths Medical Asd, Inc.
510(k) numberK211634
Submission
- Device name
- Hypodermic Needle-Pro EDGE Safety Device
- Applicant
- Smiths Medical Asd, Inc.
Plymouth, MN, US - Received
- May 27, 2021
- Decision date
- August 26, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FMI – Needle, Hypodermic, Single Lumen
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5570
- Specialty
- General Hospital
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| K254273 | Verisafe Safety Sterile Needles (SSN)FMI · Special | Promisemed Hangzhou Meditech Co., Ltd. | 04/16/2026SE |
| K252908 | Easydrip Classic Pen Needle; Easydrip Plus Pen Needle; Easydrip Classic Pro Pen Needle…FMI · Special | Sandstone Medical (Suzhou), Inc. | 03/25/2026SE |
| K253047 | PressoneFMI · Traditional | Nipro Medical Corporation | 03/24/2026SE |
| K253622 | Safety Pen NeedleFMI · Traditional | Ningbo Medsun Medical Co., Ltd. | 03/18/2026SE |
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| K232943 | Hypodermic Needle-Pro® EDGE Safety Device with Low Dead Space SyringeQNQ · Traditional | 05/31/2024SE |
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| K181699 | Level 1 Convective WarmerDWJ · Traditional | 07/26/2018SE |
| K172800 | Portex® Lancet Point Spinal Needles with NRFit connectors, Portex® Pencil Point Spinal…MIA · Traditional | 06/14/2018SE |
| K172823 | Portex NRFit Epidural NeedlesBSP · Traditional | 06/12/2018SE |
| K172410 | Portex NRFit Epidural Needles, Portex NRFit Spinal Needles, Portex NRFit Loss of…BSP · Traditional | 06/01/2018SE |
| K172592 | CADD Yellow High Volume Administration Set with NRFit connectorPWH · Traditional | 05/17/2018SE |
| K173912 | BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUperc Percutaneous…JOH · Traditional | 05/08/2018SE |
| K171968 | EchoGlo NeedleBSP · Traditional | 01/25/2018SE |
Questions and answers
When was Hypodermic Needle-Pro EDGE Safety Device cleared by the FDA?
Hypodermic Needle-Pro EDGE Safety Device (K211634) received a 510(k) decision of Substantially Equivalent on August 26, 2021, 91 days after the submission was received.
What is the product code of K211634?
The FDA product code is FMI – Needle, Hypodermic, Single Lumen, a Class II (moderate risk) device regulated under 21 CFR 880.5570.